Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study: Uptake, Outcome, and Risk Factors for Treatment Failures in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of participants by characteristics
研究概览
简要总结
This study aims to characterize Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen, assess adherence to Swiss label indications, and describe treatment outcomes in this large, multicentre, heterogeneous, high-income setting. Moreover, the study aims to assess virological, immunological, demographic, clinical, and behavioural factors associated with viral failure under CAB+RPV LA regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in the SHCS
- •All SHCS participants initiating the CAB+RPV LA regimen
- •All SHCS participants on SOC oral regimen
排除标准
- •Not participating in the SHCS
研究组 & 干预措施
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: VOCABRIA 30Mg Tablet (Drug)
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: EDURANT 25Mg Tablet (Drug)
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: Cabotegravir Injectable Suspension (Drug)
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: Rilpivirine Injectable Suspension (Drug)
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: Intact proviral DNA assay (Biological)
Swiss HIV Cohort Study participants on CAB+RPV LA regimen
Swiss HIV Cohort Study participants initiating the CAB+RPV LA regimen
干预措施: Full-length sequencing (Biological)
Swiss HIV Cohort Study participants on a standard of care oral regimen
Matched control population on a standard of care oral regimen
干预措施: Intact proviral DNA assay (Biological)
Swiss HIV Cohort Study participants on a standard of care oral regimen
Matched control population on a standard of care oral regimen
干预措施: Full-length sequencing (Biological)
结局指标
主要结局
Proportion of participants by characteristics
时间窗: Month 24
- Proportion of participants by socio-demographic and clinical characteristic(s) (e.g., by age, sex, body mass index, race, geographic origin, education, transmission mode, HIV-1 RNA levels, CD4 cell count, duration of HIV-1 infection, HIV-1 subtype, previous regimen, genotypic resistance profile, coinfections, lifestyle variables, and co-medications)
Overall adherence to Swiss label indication in CAB+RPV LA prescriptions
时间窗: Month 24
- Overall adherence to Swiss label indication in CAB+RPV LA prescriptions between care providers, such as university hospital versus private physicians, and among nationwide centres
Proportion of individuals with viral blips
时间窗: Month 24
Proportion of individuals with viral blips (defined as one HIV-1 RNA \>50 and \<400 c/mL with a next HIV-1 RNA \<50 copies/ml)
Time to viral failure
时间窗: Up to month 24
Overall time to confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of participants who discontinue treatment due to drug-unrelated reasons
时间窗: Month 24
Proportion of participants who discontinue treatment due drug-unrelated reasons and re-suppression regimens (such as patient wish, death, migration, and loss to follow-up) including the choice of re-suppression regimens.
Overall adherence to the proposed injection schedules
时间窗: Month 24
- Overall adherence to the proposed injection schedules quantified by deriving an CAB+RPV LA adherence threshold (e.g., accounting for any missed injection, daily oral bridging ART, and delayed injection of +7 days according to the Swiss label indication)
Proportion of individuals with confirmed viral failures
时间窗: Month 24
Proportion of individuals with confirmed viral failures (defined as two consecutive HIV-1 RNA ≥ 50 c/mL)
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen
时间窗: Month 24
Proportion of individuals switching off CAB+RPV LA to previous or another oral regimen after HIV-1 RNA levels of \>50 to \<400 copies/mL and \>400 copies/mL
Proportion of participants who discontinue treatment due to drug-related reasons
时间窗: Month 24
Proportion of participants who discontinue treatment due drug-related reasons and re-suppression regimens (such as adverse events, confirmed viral failure, low level viremia or low blood concentration measurements) including the choice of re-suppression regimens.
Proportion of participants by treatment adherence category
时间窗: Month 24
- Proportion of participants by treatment adherence categories (e.g., optimal, sub-optimal, and poor adherence)
次要结局
- Measure intact proviral DNA as potential predictor for viral failure(Month 24)
- Assessment of resistance associated mutations from proviral DNA as potential predictor for viral failure(Month 24)
- Investigate in-depth factors associated with viral blips and viral failure(Month 24)